[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625787":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":42,"interventions":36,"overallOfficials":36,"centralContacts":36,"locations":36,"responsibleParty":49,"collaborators":36,"id":53,"slug":36,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":36,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":36,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":36},{"fullName":5,"class":6},"University of Gaziantep","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Postoperative Airway-Related Complications","Presence of postoperative sore throat, hoarseness, dysphagia, cough, or laryngeal edema.","Postoperative day 1",[14,18,21,24,28,32],{"measure":15,"description":16,"timeFrame":17},"Severity of Postoperative Sore Throat","Assessed using a Visual Analog Scale (VAS, 0-10).","1 hour, 6 hours and 24 hours after extubation.",{"measure":19,"description":20,"timeFrame":12},"Incidence of Hoarseness","Patient-reported hoarseness evaluated by direct questioning.",{"measure":22,"description":23,"timeFrame":12},"Incidence of Dysphagia","Patient-reported difficulty in swallowing.",{"measure":25,"description":26,"timeFrame":27},"Measured Endotracheal Cuff Pressure","Recorded cuff pressure value (cmH₂O) immediately after intubation.","Intraoperative - immediately after intubation",{"measure":29,"description":30,"timeFrame":31},"Duration of Intubation","Time from intubation to extubation (minutes).","Intraoperative period (from intubation to extubation)",{"measure":33,"description":34,"timeFrame":35},"Length of Post-Anesthesia Care Unit (PACU) Stay","Duration of stay in PACU (minutes).","Postoperative period - from PACU admission to PACU discharge (same day of surgery).",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"CASE_CONTROL","PROSPECTIVE","Endotracheal intubation is routinely performed in patients undergoing surgery under general anesthesia. Maintaining appropriate endotracheal tube cuff pressure is critical to ensure adequate ventilation, prevent aspiration, and minimize tracheal mucosal injury. Excessive cuff pressure may compromise tracheal mucosal perfusion and increase the risk of postoperative airway-related complications such as sore throat, hoarseness, cough, dysphagia, and laryngospasm. Conversely, insufficient cuff pressure may lead to air leakage and aspiration risk.\n\nIn routine clinical practice, cuff pressure is frequently assessed using conventional subjective methods such as manual palpation of the pilot balloon. However, this technique does not provide an accurate measurement and may result in pressures outside the recommended safe range (20-30 cmH₂O). Direct measurement using a manometer allows objective monitoring and adjustment of cuff pressure within the optimal range, potentially reducing airway mucosal damage and postoperative laryngeal complications.\n\nThis prospective observational study aims to compare two approaches to cuff pressure management in adult patients undergoing elective surgery under general anesthesia with endotracheal intubation:\n\nPatients whose cuff pressure is measured and maintained within the optimal range using a manometer\n\nPatients whose cuff pressure is assessed using conventional methods such as palpation\n\nThe primary outcome is the incidence of postoperative airway-related complications within the first 24 hours after extubation. These include sore throat, hoarseness, cough, dysphagia, and laryngospasm.\n\nSecondary outcomes include the severity of postoperative sore throat assessed using a Visual Analog Scale (VAS), the incidence of individual airway symptoms, measured cuff pressure values, duration of intubation, length of stay in the post-anesthesia care unit (PACU), and overall postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire.\n\nEligible patients will be prospectively followed during the intraoperative period and evaluated postoperatively at predefined time points (e.g., 1, 6, and 24 hours after extubation). Demographic data, perioperative variables, and airway-related outcomes will be recorded and analyzed to determine whether objective cuff pressure monitoring with a manometer is associated with improved postoperative airway outcomes compared with conventional subjective assessment methods.\n\nThis study is expected to provide clinically relevant evidence regarding optimal endotracheal cuff pressure management and its impact on postoperative airway morbidity.","The study population will consist of adult patients aged 18-75 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index between 18 and 30 kg\u002Fm², who are scheduled to undergo elective surgery under general anesthesia requiring endotracheal intubation. Only patients with successful intubation on the first attempt will be included.",[43,46],{"label":44,"type":36,"description":45,"interventionNames":36},"Manual Palpation","Patients whose endotracheal cuff pressure was maintained using the manual palpation method.",{"label":47,"type":36,"description":48,"interventionNames":36},"Cuff Pressure Manometer","Patients whose endotracheal cuff pressure was maintained using the cuff manometer method.",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Ezgi Abay","Anesthesiology and Reanimation Assistant Doctor","100625787",false,"NCT07427173","The Impact of Endotracheal Cuff Pressure Assessment Using a Cuff Pressure Manometer Compared With the Traditional Palpation Method on Postoperative Outcomes","ECP","Inclusion Criteria:\n\n* Patients aged 18-75 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Body mass index (BMI) between 18 and 30 kg\u002Fm²\n* Undergoing surgery under general anesthesia\n* Successful endotracheal intubation on the first attempt -Provided written informed consent and willing to participate in the study-\n\nExclusion Criteria:\n\n* Patients younger than 18 years or older than 75 years\n* American Society of Anesthesiologists (ASA) physical status IV-VI\n* Patients undergoing head and neck surgery\n* History of chronic pulmonary disease (e.g., asthma, chronic obstructive pulmonary disease)\n* Presence of preoperative sore throat\n* History of upper or lower respiratory tract infection within the past 2 weeks\n* Use of systemic steroids in the preoperative period\n* More than one attempt required for endotracheal intubation\n* Emergency surgeries\n* Refusal to participate in the study",true,"ALL","18 Years","75 Years",{"count":64,"type":65},104,"ESTIMATED","1 Day","OBSERVATIONAL","The aim of this prospective observational study is to evaluate the effect of endotracheal cuff pressure management on postoperative complications in patients undergoing surgery under general anesthesia. Specifically, patients whose endotracheal cuff pressure is maintained at an optimal level using a manometer will be compared with those whose cuff pressure is assessed using the conventional palpation method.\n\nThe primary question the study aims to answer is whether maintaining endotracheal cuff pressure at an optimal level with a manometer reduces the incidence of postoperative airway-related complications compared with the classical palpation technique.",[70],"Postoperative Airway Complications",[72,73,74],"Postoperative airway complications","Endotracheal cuff pressure management","General anesthesia","NOT_YET_RECRUITING","2026-02-21",{"date":78,"type":79},"2026-02-24","ACTUAL",{"date":81,"type":65},"2026-02-18",{"date":83,"type":65},"2026-09-01",{"name":5,"class":6}]